Role of Diaphragm Fatigue in Weaning From Mechanical Vent... | NCT01135121

Studies
Role of Diaphragm Fatigue in Weaning From Mechanical Ventilation

NCT01135121

Sponsor

University Medical Center Nijmegen

Status

Unknown status

Last Update Posted

Jun 10, 2015Estimated

Enrollment

20Estimated

Phase

Not provided

Conditions

Weaning
Respiratory Muscle Function

Interventions

Not provided

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2010

Primary Completion Date

Jan 2016Estimated

Completion Date

Jan 2016Estimated

First Submitted Date

Jun 1, 2010

First Submission Date that Met QC Criteria

Jun 1, 2010

First Posted Date

Jun 2, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 9, 2015

Last Update Posted Date

Jun 10, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Leo Heunks, MD PhD, University Medical Center NijmegenPrincipal Investigator

Lead Sponsor

University Medical Center NijmegenOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine whether the diaphragm develops contractile fatigue during a weaning trial and if this is associated with weaning failure.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fatiguability of the diaphragm		Multiple measurements within 24 hours after start of weaning trial

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age > 18 year
mechanical ventilation for at least 3 days
the treating physician judges the patient to be ready to be weaned from the ventilator
informed consent

Exclusion Criteria:

pre-existent muscle disease (congenital or acquired) or diseases / disorders know to be associated with myopathy including auto-immune diseases.
upper airway / esophageal pathology (i.e. recent surgery, esophageal varices, diaphragmatic hernia)
recent (< 1 month) nasal bleeding
phrenic nerve lesions

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

ICU patients weaning from mechanical ventilation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Leo Heunks, MD, PhD	Contact	+31 24 3617273		L.Heunks@ic.umcn.nl

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Radboud University Nijmegen Medical Center	Recruiting	Nijmegen	Gelderland	6525GA	Netherlands

Label	Type	Description	Intervention Names
Weaning failure
Weaning succes